Tracheotomy instrument

ABSTRACT

A novel tracheotomy instrument adapted to be used in emergency situations comprising an arcuate trocar with a flange at one end, a concentrically arranged hollow, arcuate cannula having a flange abutting the trocar flange at one end and a beveled knife edge extending from the trocar at the opposite end.

United States Patent Inventors Edward J. Calhoun 578 Hunt Lane, Manhasset, N.Y. 11030; Karoly G. Pinter, 1626 S. Jefferson Davis Parkway, New Orleans, La. 70125 713,353

Mar. 15, 1968 Jan. 19, 1971 Appl. No. Filed Patented TRACHEOTOMY INSTRUMENT 4 Claims, 5 Drawing Figs.

11.5. C1 128/347, 128/351 Int. Cl A61b 17/34 Field of Search 128/305, 347, 351

[56] References Cited UNITED STATES PATENTS 2,865,374 12/1958 Brown etal 128/351X 3,182,663 5/1965 Abelson 128/305 3,334,631 8/1967 Stebleton 128/351 FOREIGN PATENTS 578,801 6/1933 Germany 128/347 Primary Examiner-L. W. Trapp AnorneySherman and Shalloway ABSTRACT: A novel tracheotomy instrument adapted to be used in emergency situations comprising an arcuate trocar with a flange at one end, a concentrically arranged hollow, arcuate cannula having a flange abutting the trocar flange at one end and a beveled knife edge extending from the trocar at the opposite end.

PATENTEU JAN! 9 1971 INVENTORE EDWARD J. CALHOUN KAROLY e. PINTER JW Q 52%;

ATTURNLY TRACHEOTOMY INSTRUMENT This invention broadly relates to tracheotomy instruments. More specifically, this invention relates to a tracheotomy instrument intended to be used in emergency situations when elective surgery is precluded. The novel tracheotomy instrument of this invention comprises an arcuate hollow trocar with a knife edge which may be inserted into a patients trachea immediately providing an artificial airway through said shaft and through a concentric cannula which is to remain in place.

The present invention relates to an instrument which is capable in skilled or semiskilled hands, of making a rapid opening into the trachea of a person whose airway has been suddenly blocked by a foreign body, such as a piece of meat, or other substance during deglution. Although the instrument may be used in an operating room by a surgeon performing an elective tracheotomy, its prime object is in emergency situations such as above mentioned. There are of course many other emergencies in this category other than aspiration of foreign bodies into the larynx. Among these should be mentioned allergic reactions to whatever the allergen may be, such as a drug or food or pollen, etc., which on occasion are manifested by sufficient edema of the glottis to block the air way. In addition to foreign body aspirations, allergic and anaphalactic reactions, there are many diseases and injuries wherein tracheotomy suddenly becomes a necessity to aspirate secretions blocking the airway. Suffice it to say that whatever the cause, when the airway has been completely blocked, anoxia sets in rapidly, manifested by cyanosis, coma and death, all within 3 to 5 minutes of the blockage.

Unfortunately many people die every year from blocked airway, some even when physicians or surgeons are present, who are unable to help because they have no means at hand to do a rapid tracheotomy.

There is no substitute for a surgically performed elective tracheotomy done in an operating room from the standpoint of low risk to the patient from the procedure per se. Conversely there is also no question that the emergency tracheotomy done on a battlefield or a site of an accident, or at a bedside, or in a restaurant, home, or other place, carries a greater risk from bleeding, subsequent infection, etc. The very nature of the emergency, however, is such that if initial attempts of removing the obstruction to the airway have failed, rapid tracheotomy will be lifesaving, risks not withstanding.

In extreme cases, where air flow is completely blocked the patient will die in a matter of 3 to 5 minutes. Such cases frequently occur in restaurants and homes and at accident sites and battlefields. Naturally, these places are not likely to be staffed with trained physicians or surgeons and even if one is present the means at hand have not usually been adequate to perform a successful tracheotomy.

In the past, certain devices have been developed which may be used in emergency situations to perform a tracheotomy. Some devices involve complicated multielement instruments which cannot be used by relatively unskilled personnel.

One of these is a cricothyroidotomy needle which is inserted through the cricothyroid membrane. This is technically not a tracheotomy instrument, but nevertheless establishes an air passageway into the trachea. The site of the cricothyroid membrane would be the ideal location for emergency procedures because it is more fixed, just subcutaneous, and less likely to be a site of bleeding. Unfortunately the area is so small that only a needle type instrument and not an adequate cannula-trochar instrument can be used. The question naturally arising is whether the cross sectional diameter of the inserted needle is sufficient to carry enough oxygen to be used as an emergency airway till a more definitive tracheotomy could be done. Other instruments have multiple blades, ingenious interlocking devices, ball tipped blades, etc., etc. Some require previous incision by a scalpel or other knife before they can be used. But, for the reasons noted above, the devices for incision at this site are not satisfactory since they must be so small air flow is limited. Additionally, other disadvantages of such devices are that solid needles which do not establish immediate air flow are used. After incision, therefore, time consuming steps must be performed before the airway is established.

The essential criteria of any emergency tracheotomy instrument can be expressed in two words: simplicity and adequacy. The more gadgets or paraphernalia that are added to the instrument, the more the purpose of the instrument is defeated. The ideal instrument in this reference although stripped of tempting refinements is one that will rapidly establish an adequate airway and maintain it. Likewise one that can be inserted by a semiskilled person such as a corpsman or first aid trained individual.

In view of the need for an instrument which can be used for emergency tracheotomy, this invention provides a novel tracheotomy device which can be satisfactorily used in emergency situations with reduced risks to the patient and with less skill being required of the user. Briefly, the novel tracheotomy instrument comprises a trocar with a knife edge which is plunged through the skin of the neck into the trachea without prior scalpel incision having to be made. The trocar is formed of an arcuate hollow tube having a flange and a knife edge and a concentric arcuate cannula with a flange. The flanges abut at the proximal end of the instrument and the knife edge extends from the distal end of the instrument. The knife comes to a sharp point and its edges are razor sharp and beveled to facilitate incision. Since the concentric tubes are hollow, im-

mediate air flow is achieved.

In view of the fact that an adequate artificial airway must be provided almost immediately when the natural airway is suddenly and completely blocked, it is desirable to provide a device which can be inserted and left in the trachea in a single movement. Accordingly, this invention by using concentric tubes, allows the element which is to be retained in the throat to be initially inserted simultaneously with the cutting element. After insertion the sharp edged cutting trocar is removed and the artificial airway which was concentrically arranged during incision is secured in place by cloth tape brought around the neck and tied to both sides of the flange.

Slots or other type openings on the flange permit holding the outer cannula in place after insertion and setting into position, either by using cloth tape tied around the neck or a rubberized band with metal shots that would hold at the slots. The sharp edged cutter must be removed to avoid damage to the anterior tracheal wall which could result from movement of the patient or the knife if left in place. Thus, another advantage of the present invention resides in the ability to simultaneously insert and cut, followed by removal of the cutter and retention of the airway, Once incision is made an airway is immediately established since the knife edged trocar is hollow and does not block air flow through the cannula.

It is a primary object of this invention to fill the need for a simple but safe emergency tracheotomy instrument.

Another object is to provide a tracheotomy instrument which comprises two concentric arcuate tubes adapted to be pressed into the trachea.

A further object is to provide the subject tracheotomy instrument which can be used either in emergency or nonemergency situations.

Still another object is to provide a tracheotomy instrument which enables an originally inserted cannula to be retained in position to provide an artificial airway to the trachea.

Other advantages and objects will be apparent from a consideration of the description given hereinafter and of the drawings wherein like numerals represent like elements and wherein:

FIG. 1 is an exploded view showing the components of the novel tracheotomy instrument;

FIG. 2 is a side view showing the assembled components of the novel tracheotomy instrument;

FIG. 3 is a view along lines 3-3 of FIG. 1 showing the trocar and flange of this invention;

FIG. 4 is a view along lines 4-4 of FIG. 1 showing the inner trocar with flange and knife edge according to this invention; and

FIG. 5 is a perspective view of the cannula flange according to this invention.

In the FIGS. the following major components are illustrated:

2cannula; 4 4--cannula flange;

6locking device; 8trocar; 10trocar flange; and 12-knife edge. Referring now to the FIGS. and particularly to FIG. 1, the novel tracheotomy instrument according to this invention is shown. Cannula 2 comprises a hollow arcuate, outer cannula defining an arc of approximately 90. The proximal end of cannula 2 is provided with an attachment part 14 having extensions 16. Attachment part 14 and extensions 16 are used to secure the cannula 2 to cannula flange 4. Cannula flange 4 also has a locking device 6. The cannula 2 may be of any suitable size, the dimensions will vary but standard sizes may be manufactured for selected classes of persons. For example, one size can be used for children, another for adult females, and another for adult males. Other reasonable classifications may be made and more specific breakdowns may be included within any given classification. The essential factor is to provide a cannula having a diameter adequate to supply sufficient airflow; this dimension will vary somewhat with adults needing a larger diameter than children, for example a diameter of about 54 inch has proven satisfactory for adults and a diameter of about a inch is used for children. The dimension which will vary most with the different classes of persons is the length of the cannula. The length should be such that upon fully inserting the instrument at a point about one inch (two fingers width) above the sternal notch in the midline of the neck the instrument will pass through the subcutaneous tissue and pretracheal fascia into the tracheal lumen. For adults, a satisfactory length is approximately 2 inches and for children a length of approximately 1% inches is satisfactory. The dimensions given herein are merely by way of example, it being obvious that the exact dimensions will depend on the class of persons being treated. The materials of construction used in making the instrument vary widely, such materials as the stainless steels are useful as well as silver, aluminum vitallium, alloys,

and those plastics such as polyethylene and polypropylene which have sufficient strength and suitable physical properties to be formed into a cannula. The method of forming the cannula is not essential to this invention and any conventional method of forming hollow arcuate tubes may be used.

Returning to FIG. 1, the cannula flange 4 is shown as being a thin sheet attached by any suitable method to the cannula 2 at its proximal end. The cannula flange 4 may also be seen in FIGS. 3 and 5.

In FIG. 3, the cannula flange 4 is shown as having strips 18 which engage and secure extensions 16 on cannula 2. This is, of course, only one specific manner of attaching the cannula 2 and cannula flange 4 and any other attachment may be used such as a welded joint. Cannula flange 4 also has struck-out curlicue slots 20 positioned adjacent the strips 18. These curlicue slots will engage a support for holding the cannula in place on the neck after incision. One support can be a chain formed of a series of balls commonly used in key chains. The ball on each end of such a chain is engaged in each curlicue slot 20 and this chain encircles the neck to support the cannula in position. A stretchable rubberized band with slots at each end csn also be used. The slots 22 serve as additional support engaging slots. A tape or ribbon not shown, may be threaded through these slots and tied and also passed around the neck. Either one of the supporting elements described may be used. As seen in FIGS. 1 and 2, the strips 18 are slightly curved and thus are raised from the plane of the cannula flange 4 to engage extensions 16.

The cannula flange 4 curves slightly to enable the said flange to fit the curvature of the neck at the point of incision. This curvature is seen in FIG. 5. The curvature is slight and a generally V-shape results from the curvature. The angle B defined by the curved flange is between 135 and 180 with the precise angle varying according to the other dimensions of the instrument, i.e., a larger angle is used with small cannulas and a smaller angle is used with the larger cannulas. The overall length of the cannula flange 4 is about 1% to 2 inches, with the point of bending provided at about its center. The cannula flange may further be formed with its edges turned down so that a slight hollow space is provided as seen in FIG. 5.

The locking device 6 comprises an extension 6 having a flaglike protuberance 24. The locking device 6 extends through an aperture in cannula flange 4 and has a smaller diameter than the aperture so that the locking device can pivot 360 in the aperture. The flaglike protuberance 24 can be pivoted to an unlocked position (FIG. 1) and a locked position 180 removed therefrom (FIG. 2). In the locked position, the said protuberance 24 engages the inner trocar flange l0 preventing relative movement between the inner trocar 8 and cannula 2.

The inner trocar 8 is shown in FIG. 2 as being a hollow arcuate shaft concentrically arranged within cannula 2. In the assembled position (FIG. 2) the distal end of trocar 8 extends from cannula 2. This extending end is beveled and sharpened to provide a knife edge 12. The knife edge bevel is provided at an angle A with the arcuate axis of the trocar (See FIG. 1) and the edges are sharpened. Angle A forms an acute angle with the tangent to the arcuate axis at the plane of the bevel. The geometry of the knife edge in the plane of the bevel is shown as being oval in FIG. 4. It is to be understood that other suitable geometry may be provided to improve the cutting action of knife edge 12. For example, it is common in puncturing needles to provide an oval, a diamond shaped, or other surfaces in the plane of knife edge 12. This invention encompasses any suitable geometry, the oval being shown by way of specific example.

Returning to FIG. 1, the trocar 8 is also provided with a trocar flange 10 which is arranged at the proximal end of said trocar. Trocar flange 10 comprises an attachment section 26 with struck-out section 30 and ears 28 (See Fig. 4). The attachment section 26 provides an area for attaching the trocar 8 to the trocar flange 10 by any suitable method. The struckout section 30 enables locking device 6 to pivot. If struck-out section 30 were not provided, attachment portion 26 would abut locking device 6 and prevent pivotal movement of the locking device 6. Bars 28 are raised from the plane of trocar flange 10 as seen in FIGS. 1 and 2. By being raised, a user can grasp the ears 28 and pull the trocar 8 out of engagement with cannula 2. The materials used to make the inner trocar 8 and trocar flange 10 are the same as those used for the cannula 2 and cannula flange 4.

By way of review of the essential features of this structure, the instrument of the present invention has a design similar to the conventional tracheotomy tube that is left in situ after the usual elective tracheotomy is performed. The are or arcuate shape conforms to a quarter circle subtending approximately a angle. The outer cannula, however, is 1.5 cm. shorter than the longer inner trocar knife. In other words, the inner trocar knife portion extends about 1.5 cm. beyond the end of the outer cannula. The inner knife trocar has a small flange at its proximal end which encircles but does not narrow the opening. In addition, it has two small elevated flanges at 3 and 9 o'- clock to facilitate removal of the inner knife trocar as soon as the airway has been established. The outer cannula which is the one that remains indwelling has a slightly curved flange roughly corresponding to the horizontal curve of the neck with its long axis extending from 3 to 9 o'clock extending about 2.5 cm. on either side of the center of the instrument. It also contains slight indentations on the side that would approximate the skin which would conform to the curve of the palmar surface of the index and middle fingers. These are used one on either side of the cannula as the gripping fingers which together with the thumb would be the control fingers used to plunge the instrument into the trachea.

The procedure of the tracheotomy of the instant invention is done as follows:

Having with considerable haste determined that no means short of emergency tracheotomy will save the patients life, preliminary attempts to dislodge the blockage having failed and no air exchange is taking place, the patient is placed supine, face up with neck hyperextended. A rapid cleaning of the skin of the neck with alcohol or any available antiseptic is done (if time allows-otherwise dispense with it) making sure the position is such that the trachea is in the midline and is held firmly between the thumb and index finger of one hand. The instrument, both outer cannula and inner trocar together is then plunged through the skin about 2 fingers breadth above the sternal notch in the midline of the neck, through the subcutaneous tissue and pretracheal fascia into the trachea. When the sharp inner knife trocar has led the outer cannula with it into the tracheal lumen, the airway is established because the inner trocar, at the end of which is the knife, is hollow as well as the outer cannula. This is an advantage over stylettes or solid type trocars, which have to be removed before the airway is established. When the outer cannula is about halfway into the trachea, the inner knife trocar is partially withdrawn into it being so thus effectively sheathed that the knife portion is not a possible hazard to puncture the anterior wall of the trachea from the inside at a site below the portal of entry. The outer cannula is then set flush with the skin of the neck as the inner knife trocar is simultaneously withdrawn. The indwelling cannula is then held in place by a string of cloth tape or rubberized band around the flange. if the patient needs further management to revive, mouth to tracheotomy tube breathing can be instituted, or other forms of artificial respiration may be used. If oxygen is available, it can be fed into the tracheotomy tube by a small catheter or polyethylene tube. Once respiration is reestablished and cyanosis has disappeared, the patient may be transported still in the prone position to a hospital or similar facility relatively leisurely once an adequate airway is established and respiration and heart beat have stabilized, other things being equal, the extreme emergency is over.

Reference to the accompanying drawings is herewith made. The ideal overall size for an emergency tracheotomy instrument corresponds to the lower range of conventional tracheotomy tubes from about size 4 through size 6 although smaller or larger diameters may be used. In adults, in elective tracheotomies the tendency is to use the larger diameter airways. ln emergency tracheotomy, adequate airway can be established with less risk from trauma, by the use of the smaller cross-sectional instrument. This is especially true if no piece of trachea is removed as is done in the usual elective tracheotomy. lf later a larger opening is desired, it can be done in a hospital operating room after the emergency is over.

One important advantage is that during all these and subsequent operational steps an airflow is allowed since both the trocar and cannula are hollow. The cannula is now attached to the neck by a chain or tape which extends through the cannula flange slots. if required, artificial respiration can be performed through the artificial airway established through the indwelling cannula.

The instrument should also be able to be autoclaved or solution sterilized. A small readily removable plastic or light metal long thimblelike sheath should be included. This would fit over the assembled instrument's protruding knife-trocar to preserve and protect the sharpness of its point and blade edges. The entire instrument can be sterilized and packed into a glassine or polyethylene or other type plastic encasement such as is presently in use for many sterile disposable surgical instruments. It can be transported in doctors bags or carried on their persons, or as an item in first aid kits wherever they may be located such as in factories, offices, restaurants, etc. Medical corpsmen in our services would be able to include such a nonbulky light weight instrument in hospital and field equipment. in hospitals, the operating rooms, emergency rooms, and nurses stations should have the instrument as a part of their emergency equipment. If medical students, interns and residents, nurses, corpsmen, police and firemen and others takin first aid training as in Red Cross programs, were trained in t e technique of emergency tracheotomy such as herein proposed, a sizeable segment of the population would be qualified to perform on-the-spot tracheotomy when necessary to save lives. Many who now die from this not uncommon emergency would live.

It is understood that all the above description is given by way of example and specific dimensions, materials, etc. are merely illustrative of the invention without in any way limiting the inventive concept.

We claim:

1. In a tracheotomy instrument an arcuate hollow cannula provided with a flange portion at its proximal end, the arc of the cannula subtending an angle of approximately and an arcuate, completely hollow trocar concentrically arranged and conforming substantially to the inner surface of said hollow cannula within said cannula, said trocar provided with a flange at its proximal end and a pointed knife edge at its distal end, and being of a length compared to the length of said cannula whereby said knife edge projects beyond the cannula when said cannula and said trocar are telescopically engaged a sufficient distance to allow an incision to be made in the trachea to thereby provide an artificial airway of dimensions adequate to restore free breathing to a blocked natural airway.

2. The tracheotomy instrument of claim 1 wherein a locking device is provided in the flange of the cannula to lock the trocar within the cannula.

3. The tracheotomy instrument of claim 1 wherein the knife edge comprises a beveled portion, said bevel extending at an acute angle to a tangent to the arcuate axis of the cannula.

4. The tracheotomy instrument of claim 1 wherein the cannula flange is curved to approximate the curvature of the neck adjacent to the point of incision. 

1. In a tracheotomy instrument an arcuate hollow cannula provided with a flange portion at its proximal end, the arc of the cannula subtending an angle of approximately 90*, and an arcuate, completely hollow trocar concentrically arranged and conforming substantially to the inner surface of said hollow cannula within said cannula, said trocar provided with a flange at its proximal end and a pointed knife edge at its distal end, and being of a length compared to the length of said cannula whereby said knife edge projects beyond the cannula when said cannula and said trocar are telescopically engaged a sufficient distance to allow an incision to be made in the trachea to thereby provide an artificial airway of dimensions adequate to restore free breathing to a blocked natural airway.
 2. The tracheotomy instrument of claim 1 wherein a locking device is provided in the flange of the cannula to lock the trocar within the cannula.
 3. The tracheotomy instrument of claim 1 wherein the knife edge comprises a beveled portion, said bevel extending at an acute angle to a tangent to the arcuate axis of the cannula.
 4. The tracheotomy instrument of claim 1 wherein the cannula flange is curved to approximate the curvature of the neck adjacent to the point of incision. 